Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90yttrium Colloid for Treatment of Cystic Lesions of the Pituitary and Surrounding Areas (Sellar/Parasellar Region)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cyst shrinkage
研究概览
简要总结
There is no consensus in the literature on the best way to treat cystic lesions of the pituitary area. Patients who are symptomatic from these tumours are rare. The cystic form of tumours present special challenges since traditional treatment modalities (surgery and/or external radiation) are often not able to completely remove or treat the cyst wall without major morbidity or even mortality.
There is no 'best practice' for the treatment of cystic tumours per se. Treatments available to patients with cystic sellar/parasellar tumours include conservative management using a 'wait and scan' approach, cyst drainage, and cyst removal via transsphenoidal and/or craniotomy approach (i.e. open surgery). Over the last 10 years we have treated approximately 8 patients with intracystic radiotherapy. All of these patients continue to be monitored clinically and radiologically and all have done well with stable regression of the cysts and no new neurological deficits. Over the past 2 years, 90yttrium colloid has been provided to CDHA through Health Canada's Special Access Program (SAP). It has only been of recent that Health Canada has requested a clinical trial to assess the benefit of intracystic radiotherapy over other available treatment options.
The experimental treatment being proposed is the stereotactic intracavitary instillation of 90yttrium colloid for treatment of cystic lesions of the pituitary (sellar) and surrounding areas (parasellar).
详细描述
Surgical procedures will be performed as standard of care. The treating neurosurgeon (Dr. David B. Clarke) will determine surgical parameters based on his clinical expertise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label, patients assigned to treatment group
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages Eligible for Study: 17 years of age or older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
- •Inclusion Criteria
- •Patients who meet all of the following criteria are eligible for enrollment as study participants:
- •Patients 17 years of age or older.
- •Cystic sellar, suprasellar, parasellar or intrasellar masses diagnosed by histology, cytology or neuroimaging.
- •Tumour measurements and/or tumour volume can be calculated.
- •Patients who require surgical intervention as determined by the treating neurosurgeon.
- •Being a patient managed in the Halifax Neuropituitary Program surgical clinic.
- •Willingness to undergo surgery and give informed surgical consent.
- •Willingness to provide informed consent for study participation.
排除标准
- •Patients who meet any of these criteria are not eligible for enrollment as study participants:
- •Neurosurgeon's assessment that surgical procedures hold unacceptable operative risk.
- •Having a solid tumour.
- •Pregnant or breast feeding at time of surgical consent and/or surgery.
- •Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent (90yttrium colloid).
研究组 & 干预措施
90yttrium colloid
90 Yttrium colloid will be inserted into the cystic cavity. Based on clinical expertise, the treating neurosurgeon will determine the appropriate surgical procedure for each patient on an individual basis which will be reflected in the surgical consent the patient is presented and signs.
干预措施: 90yttrium colloid (Radiation)
结局指标
主要结局
Cyst shrinkage
时间窗: 12 months after treatment
Decreased cyst volume on MRI + resolution of clinical symptoms
次要结局
- Localization of intracystic 90yttrium colloid by PET-CT(Within 3 weeks of treatment)
研究者
David Clarke
Neurosurgeon
Nova Scotia Health Authority